OC 24.1
The Influence of Renal Impairment on Clinical Outcomes in Venous Thromboembolism Patients Enrolled in GARFIELD-VTE
S. Goto1, A.G.G. Turpie2, A. Zaghdoun3, J.I. Weitz4, S. Haas5, W. Ageno6, S.Z. Goldhaber7, P. Angchaisuksiri8, J. Dalsgaard Nielsen9, G. Kayani3, S. Schellong10, H. Bounameaux11, L.G. Mantovani12, P. Prandoni13, A.K. Kakkar3, on behalf of the GARFIELD-VTE Investigators
1Tokai University School of Medicine, Department of Medicine (Cardiology), Tokai, Japan, 2McMaster University, Hamilton, Canada, 3Thrombosis Research Institute, London, United Kingdom, 4McMaster University and Thrombosis and Atherosclerosis Research Institute, Ontario, Canada, 5Formerly Technical University of Munich, Munich, Germany, 6University of Insubria, Department of Medicine and Surgery, Varese, Italy, 7Harvard Medical School, Boston, United States, 8Ramathibodi Hospital, Mahidol University, Department of Medicine, Bangkok, Thailand, 9Copenhagen University Hospital, Copenhagen, Denmark, 10Municipal Hospital Dresden, Medical Department 2, Dresden, Germany, 11University Hospital of Geneva, Faculty of Medicine, Geneva, Switzerland, 12University degli Studi di Milano Bicocca, Milan, Italy, 13Arianna Foundation on Anticoagulation, Bologna, Italy
Main Topic: Venous Thromboembolism
Category: DOACs
Background: Venous thromboembolism (VTE) patients with concomitant chronic kidney disease (CKD) represent a complex patient group, with an increased risk of thrombosis as well as serious bleeding complications. Moreover, anticoagulation is challenging because the majority of anticoagulant drugs are excreted by kidney.
Aims: Compare the baseline characteristics, treatment patterns, and 12-month outcomes between patients with moderate-to-severe (stages 3-5) CKD and patients with normal-to-mild (stages 1-2) CKD enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.
Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. 10,685 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017, 8,939 of which (normal-to-mild CKD n=6897, moderate-to-severe CKD n=2042) were eligible for analysis in this study.
Results: The distribution of VTE events was comparable between groups (moderate-to-severe CKD: 57.1% deep vein thrombosis (DVT) alone, 42.9% pulmonary embolism (PE) ± DVT; normal-to-mild: 58.9% DVT alone, 41.1% PE ± DVT). Moderate-to-severe CKD (vs. normal-to-mild CKD) was more common in females (57.0% vs. 47.0%). Moderate-to-severe CKD patients were older; mean (standard deviation) 67.4 (14.8) years vs. 56.1 (16.6) years, but BMI; mean (standard deviation) was comparable to patients with normal-to-mild CKD: 29.2 (6.9) kg/m2 vs. 28.1 (6.5) kg/m2, respectively. Chronic heart failure (6.8% vs. 2.2%), chronic immobilisation (7.1% vs. 5.3%) and a history of cancer (17.2% vs. 12.9%) were all more common in moderate-to-severe CKD patients compared to normal-to-mild CKD patients, respectively. No clinically meaningful differences were found between treatment patterns at baseline between groups (Table 1). Over 12-months follow-up, patients with moderate-to-severe CKD were at an increased risk (hazard ratio [95% confidence interval]) of all-cause mortality (1.92 [1.63-2.26]), major bleeding (1.94 [1.41-2.68]), and recurrent VTE (1.27 [1.02-1.57]) (Table 2).
Conclusions: VTE patients with moderate-to-severe CKD are at an increased risk of major adverse outcomes.
Treatment | Moderate-to-severe CKD N (%) | Normal-to-mild CKD N (%) |
Anticoagulation therapy only | 1877 (91.9) | 6416 (93.0) |
Parenteral therapy only | 331 (17.6) | 1130 (17.6) |
Parenteral therapy + VKA | 586 (31.2) | 1658 (25.8) |
VKA only | 114 (6.1) | 311 (4.8) |
DOAC only | 514 (27.4) | 1956 (30.5) |
Parenteral therapy + DOAC | 286 (15.2) | 1209 (18.8) |
Unknown | 46 (2.5) | 152 (2.4) |
Other therapy ± anticoagulation | 123 (6.0) | 382 (5.5) |
No therapy or compression only | 42 (2.1) | 99 (1.4) |
[Treatment at baseline (± 30 days of VTE diagnosis) in moderate-to-severe CKD patients vs normal-to-mild CKD patients enrolled in GARFIELD-VTE.] Event | Moderate-to-severe CKD (N=2,022) | Normal-to-mild CKD (N=6,860) | Hazard Ratio [95% CI] | P-value |
| n | Rate per 100 person-years [95% CI] | n | Rate per 100 person-years [95% CI] | | |
All-cause mortality | 228 | 12.7 [11.2-14.5] | 413 | 6.6 [6.0-7.3] | 1.92 [1.63-2.26] | <0.0001 |
Major bleed | 58 | 3.3 [2.5-4.2] | 104 | 1.7 [1.4-2.0] | 1.94 [1.41-2.68] | <0.0001 |
Recurrent VTE | 113 | 6.6 [5.5-7.9] | 311 | 5.1 [4.6-5.7] | 1.27 [1.02-1.57] | 0.0301 |
Any bleeding | 238 | 14.4 [12.7-16.3] | 627 | 10.7 [9.9-11.5] | 1.33 [1.14-1.54] | 0.0002 |
Stroke/Transient Ischemic Attack | 20 | 1.1 [0.7-1.7] | 44 | 0.7 [0.5-1.0] | 1.59 [0.94-2.70] | 0.0858 |
Myocardial Infarction/Acute Coronary Syndrome | 23 | 1.3 [0.9-1.9] | 41 | 0.7 [0.5-0.9] | 1.95 [1.17-3.26] | 0.0101 |
[Table 2: 12-month outcomes in moderate-to-severe CKD patients and normal-to-mild CKD patients enrolled in GARFIELD-VTE.]